FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Gold Probe 7FR Working Length: 350 cm, Probe Tip O.D. 2.3 mm (7Fr), Rx Only. Electrical Connector: Standard. Single Use Only. Legal Manufacturer, Boston Scientific Corporation, One Boston Scientific Place Natick, MA 01760-1537 USA. Made in USA: 8600 N.W. 41st Street Miami, FL 33166-6202 USA. The device is indicated for use in transendoscopic electrocautery of visible bleeding and nonbleeding sites in the gastrointestinal tract including the esophagus, stomach, duodenum, and colon.
- Recall number
- Z-0979-2009
- Recalling firm
- Boston Scientific Corporation
- Product
- Gold Probe 7FR Working Length: 350 cm, Probe Tip O.D. 2.3 mm (7Fr), Rx Only. Electrical Connector: Standard. Single Use Only. Legal Manufacturer, Boston Scientific Corporation, One Boston Scientific Place Natick, MA 01760-1537 USA. Made in USA: 8600 N.W. 41st Street Miami, FL 33166-6202 USA. The device is indicated for use in transendoscopic electrocautery of visible bleeding and nonbleeding sites in the gastrointestinal tract including the esophagus, stomach, duodenum, and colon.
- Status
- Terminated
- Initiated
- 2008-12-24
- Posted
- 2009-02-13
- Terminated
- 2010-05-11
- Reason
- Packaging tray for the Gold Probe Single-Use BiPolar Electrohemostasis Catheters may have a crack. Cracks in the tray or damage to the tray of the Gold Probe device may lead to a compromised sterile barrier.
- Root cause
- Packaging process control
- Action
- A notification letter (dated December 24, 2008) was issued to customers. The letter identified the issue. Consignees are instructed to: 1) Discontinue use and segregate affected product, 2) Complete a Reply Verification Tracking Form and fax to the Boston Scientific Corporation (BSC) at 508-683-5578 and 3) Package and ship recalled product as instructed in the letter. If affected product is found, customers are instructed to call BSC Customer Service at 1-866-868-4004 between 8:30 a.m. through 6:00 p.m. (Eastern Standard Time). Please direct questions about the recall to your local Sales Representative.
- Quantity
- 10,841
- Distribution
- Worldwide Distribution.
- Lot, serial or model codes
- Lot Numbers for UPN M00560220: 9291645, 9344981, 9394026, 9416584, 9462927, 9501324, 9559362, 9581713, 9636705, 9670186, 9690901, 9741754, 9754809, 9754810, 9754811, 9815965, 9819629, 11006445, 110039853, 11042217, 11129600, 11168985, 11175063, 11234903, 11268506, 11282762, 11327776, 11361680, 11405398, 11445120, 11499437, 11522023, 11540259, 11577720, 11598340, 11647351, 11680236, 11713017, 11751140, 11786708, 11827587, 11850720, 11913776, 11943552, 11961965, 11997177 and 12077478.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KNS
- Firm FEI
- 1051710
- Firm city
- Miami
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28